FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Biomerieux 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-03-11
  • 사례 출판 날짜
    2014-03-11
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: biomerieux fb (fast blue bb), zym b reagent, api listeria, and api nh medical device manufacturer, biomerieux, has issued a field safety notice (fsn) concerning certain lots of biomerieux fb (fast blue bb) with reference number 70562, zym b reagent with reference number 70493, api listeria with reference number 10300, and api nh with reference number 10400. identification strips using the fb reagent: api campy (20800), id 32 staph (32500), rapid id 32a (32300), rapid id 32 strep (32600) identification strips using the zym b reagent: api 20 strep (20600), api coryne (20900), api staph (20500), api zym (25200), api nh (10400), api listeria (10300) the issue may result in misidentification of microorganisms. the manufacturer advises users of the followings: if users are in possession of some kits of fb reagent (70562), they should implement the mandatory requirements as mentioned in the fsn. if users are in possession of some kits of zym b (70493), api nh (10400) and api listeria (10300), they should check the aspect of zym b (70493) before each use and follow the recommendations mentioned in the fsn. users should discuss with the laboratory director to evaluate the impact and determine if any retrospective analysis of results is required. for the next batches, an insert will be added in fb reagent (70562), zym b (70493), api nh (10400) and api listeria (10300) to explain the mandatory actions required in this fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 march 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Biomerieux FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Manufacturer

Manufacturer